ArticleScientific reports2025
Establishing a GMP-compliant manufacturing process and phase-appropriate analytics for early development of a FiCAR T-cell product with a novel CAR spacer.
Article in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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Who cites it
3 citing papers in PubMed.
- Upregulation of the TCA Cycle and Oxidative Phosphorylation Enhances the Fitness of CD99 CAR-T Cells Under Dynamic Cultivation.International journal of molecular sciences · 2026Article
- Navigating CAR-T translation in Australia: lessons from an academic program.Frontiers in medicine · 2026Review
- Automated GMP-compatible production of universal CAR Tregs for organ-targeted tolerance induction.Journal of translational medicine · 2025Article
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Authors and funding
23 authors.
Funding
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Abstract
There is a growing demand for chimeric antigen receptor (CAR) -T cells for clinical trials. Consequently, new centers capable of manufacturing advanced therapy medicinal products (ATMPs) are needed. In this study, we established a good manufacturing practice -compliant manufacturing process and phase-appropriate analytics for a novel autologous CD19-targeted CAR T-cell product, 19-FiCART. We evaluated the stability of fresh, healthy donor-derived leukapheresis products (LPs), produced 19-FiCART using a 12-day semi-automated process with CD4/CD8-positive cell enrichment and lentiviral transduction, and evaluated the in vivo efficacy of 19-FiCART in a xenograft mouse lymphoma model. The optimal hold time and temperature to maintain LP stability were up to 73 h at 2-8 °C. The 19-FiCART manufacturing process consistently yielded more than 2 × 10
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